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Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma

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ClinicalTrials.gov Identifier: NCT00398138
Recruitment Status : Completed
First Posted : November 10, 2006
Results First Posted : March 2, 2016
Last Update Posted : March 2, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Innovive Pharmaceuticals
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lung Cancer
Malignant Mesothelioma
Myelodysplastic Syndromes
Primary Peritoneal Cavity Cancer
Interventions Biological: WT-1 analog peptide vaccine
Biological: incomplete Freund's adjuvant
Biological: sargramostim
Genetic: polymerase chain reaction
Other: flow cytometry
Other: immunoenzyme technique
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vaccine
Hide Arm/Group Description

Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.

WT-1 analog peptide vaccine

Period Title: Overall Study
Started 12
Completed 10
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title Vaccine
Hide Arm/Group Description

Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.

WT-1 analog peptide vaccine

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  50.0%
>=65 years
5
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
2
  20.0%
Male
8
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Safety
Hide Description Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vaccine
Hide Arm/Group Description:

Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.

WT-1 analog peptide vaccine

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
10
2.Primary Outcome
Title Immune Response
Hide Description Immune reactivity to the peptides will be measured in the same fashion for patients with hematologic or thoracic malignancies. Immune responses will be measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT will be performed as well.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vaccine
Hide Arm/Group Description:

Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.

WT-1 analog peptide vaccine

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vaccine
Hide Arm/Group Description

Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.

WT-1 analog peptide vaccine

All-Cause Mortality
Vaccine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Vaccine
Affected / at Risk (%) # Events
Total   3/10 (30.00%)    
Nervous system disorders   
Syncope   1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea   2/10 (20.00%)  2
Vascular disorders   
Edema: head and neck   1/10 (10.00%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vaccine
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Blood and lymphatic system disorders   
Lymphopenia   1/10 (10.00%) 
Platelets   4/10 (40.00%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)   4/10 (40.00%) 
Infections and infestations   
Leukocytes (total WBC)   4/10 (40.00%) 
Neutrophils/granulocytes (ANC/AGC)   2/10 (20.00%) 
Metabolism and nutrition disorders   
Albumin, low (hypoalbuminemia)   6/10 (60.00%) 
Glucose, high (hyperglycemia)   10/10 (100.00%) 
Hemoglobin   6/10 (60.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Peter Maslak, Attending
Organization: Memorial Sloan Kettering Cancer Center
Phone: +1212-639-5518
EMail: maslakp@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00398138    
Other Study ID Numbers: 06-085
P30CA008748 ( U.S. NIH Grant/Contract )
P01CA023766 ( U.S. NIH Grant/Contract )
MSKCC-06085
First Submitted: November 9, 2006
First Posted: November 10, 2006
Results First Submitted: December 22, 2015
Results First Posted: March 2, 2016
Last Update Posted: March 2, 2016